ComplianceOnline

FDA GxP Regulations and Best Practices Training, Compliance Best Practices and Standards

Life science product manufacturing best practices and GxPs based webinars, in-person seminars, standards and best practices. Learn from renowned experts about life science industry best practices and GxPs – GMP, GLP, GCP, Responding to Warning Letters and 483s, Raw material risk management, validation and testing requirements, computer systems validation, FDA documentation practices, etc.
Webinar
Performing Effective Management Review of the Quality System
19
/ May
Monday-2025

Performing Effective Management Review of the Quality System

  • Speaker: David L Chesney
  • Product ID: 704933
  • Duration: 90 Min
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
* Per Attendee
$199
Recorded/CD
US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 702029
  • Duration: 90 Min
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
CD/Recorded
$249
Recorded/CD
Major CGMP Issues - US FDA Concerns in 2022

Major CGMP Issues - US FDA Concerns in 2022

  • Speaker: John E Lincoln
  • Product ID: 702185
  • Duration: 90 Min
This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.
CD/Recorded
$299
Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
CD/Recorded
$219
Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
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